Bio Pharma Dive
NOVEMBER 17, 2021
A European Medicines Agency panel tasked with reviewing drugs voted against the biotech's controversial Alzheimer's medicine, signaling an approval is unlikely next month
BioSpace
NOVEMBER 17, 2021
Merck’s Keytruda (pembrolizumab) keeps expanding the indications for which it’s approved. The company announced today that the FDA had approved the anti-PD-1 therapy for adjuvant treatment of renal cell carcinoma.
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Bio Pharma Dive
NOVEMBER 17, 2021
Chroma Medicine's launch is the latest step in a decadeslong quest by drugmakers to capitalize on research into epigenetics, a way of controlling gene expression without altering DNA.
BioSpace
NOVEMBER 17, 2021
?The strategic collaboration entails a $180 million equity investment into Owkin and a total payment of $90 million over the next three years, in addition to milestone-based fees to be determined later.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
NOVEMBER 17, 2021
The Boston biotech, shares of which soared last year on hopes for the antiviral drug, said it has plenty of money to advance development on its own.
Pharma Times
NOVEMBER 17, 2021
This deal will see more patients having access to treatment which could prevent 21,700 strokes and 5,400 deaths
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
NOVEMBER 17, 2021
Following a soft launch in select markets, the beverage buffs behind Oatly and Fiji Water have teamed up to develop Good Idea , a functional beverage that will soon debut in the US. While the line was initially launched in 2018 under the name “The Swedish Sugar Buster,” the re-launch features new packaging and flavors that are more suitable for today’s functional beverage market.
BioSpace
NOVEMBER 17, 2021
Gilead Sciences announced it exercised its options to three of Arcus Biosciences’ programs. Two are anti-TIGIT molecules, domvanalimab and AB308, and the other is etrumadenant and quemliclustat.
pharmaphorum
NOVEMBER 17, 2021
Armed with impressive new data for its oral antiviral Paxlovid, Pfizer has filed for emergency use authorisation as a COVID-19 treatment in the US – and signed a deal to allow other manufacturers to make it in some lower-income countries. Paxlovid – based on new protease inhibitor PF-07321332 and HIV drug ritonavir – was found to reduce the risk of hospitalisations and death in mild to moderate COVID-19 patients by 89% compared to placebo when given in the early stages of infection.
BioSpace
NOVEMBER 17, 2021
Biopharma and life sciences companies from across the globe provide updates. Belgium-based Galapagos NV won European approval for Jyseleca for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
pharmaphorum
NOVEMBER 17, 2021
Biogen and Eisai have said that the EMA’s human medicines committee looks unlikely recommended approval of their Alzheimer’s drug Aduhelm when it comes up for discussion next month. The CHMP had a “negative trend vote” on the drug at a meeting last week which included an “oral explanation” of Aduhelm (aducanumab), which was approved in controversial circumstances by the US FDA earlier this year.
BioSpace
NOVEMBER 17, 2021
Generate Biomedicines, a machine-learning protein-therapy company, raked in $370 million in a Series B financing round that will be used to advance the company’s developmental programs.
Scienmag
NOVEMBER 17, 2021
A team of researchers from University of Toronto Engineering and Rice University have reported the first measurements of the ultra-low-friction behaviour of a material known as magnetene. The results point the way toward strategies for designing similar low-friction materials for use in a variety of fields, including tiny, implantable devices. Credit: Daria Perevezentsev / University of Toronto […].
BioSpace
NOVEMBER 17, 2021
Novo Nordisk and Dicerna are no strangers. The companies have been collaborating on the development of RNAi therapies for liver disease for the past three years.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
Scienmag
NOVEMBER 17, 2021
For years, researchers believed that the smaller the domain size in a ferroelectric crystal, the greater the piezoelectric properties of the material. However, recent findings by Penn State researchers have raised questions about this standard rule. Credit: Chane Research Group, Penn State For years, researchers believed that the smaller the domain size in a ferroelectric […].
BioSpace
NOVEMBER 17, 2021
?The Richard King Mellon Foundation has awarded a $100 million gift to the University of Pittsburgh and approved a $150 million grant for Carnegie Mellon University.
BioPharma Reporter
NOVEMBER 17, 2021
The company will increase its production capacity for media, buffers, and other process liquids to meet the surge in demand that occurred alongside the pandemic.
BioSpace
NOVEMBER 17, 2021
?Based on BridgeBio's current pipeline of programs, this total amount will be sufficient to carry over 30 drug development and discovery programs well into 2024.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Scienmag
NOVEMBER 17, 2021
MINNEAPOLIS / ST. PAUL (11/17/2021) — An international team of researchers from the University of Minnesota Twin Cities and Kiel University in Germany have discovered a path that could lead to shape-shifting ceramic materials. This discovery could improve everything from medical devices to electronics. Credit: Gu, et al., University of Minnesota and Kiel University MINNEAPOLIS / […].
BioSpace
NOVEMBER 17, 2021
The FDA and CDC will soon decide on Pfizer-BioNTech’s request for an Emergency Use Authorization for the booster shot for their COVID-19 vaccine.
Scienmag
NOVEMBER 17, 2021
The term “greenhouse effect” became part of public lexicon decades ago, thanks to the ongoing discourse on climate change. A natural phenomenon, the greenhouse effect describes how heat from the sun, in the form of radiation, is trapped by gases in the Earth’s atmosphere. But a large amount of radiation is still lost to outer […].
BioSpace
NOVEMBER 17, 2021
Monoclonal antibodies have proven to be an important therapeutic option in the ongoing battle against COVID-19.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
Scienmag
NOVEMBER 17, 2021
Nutley, NJ, November 17, 2021 – The secret to melanoma’s metastatic spread could be a complex natural pathway it hijacks – one which may be a therapeutic target in combination with other targeted therapies and immunotherapies, according to new research published by Hackensack Meridian Center for Discovery and Innovation (CDI) scientists. Credit: Hackensack Meridian Health […].
Pharma Times
NOVEMBER 17, 2021
This marks the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA)
Scienmag
NOVEMBER 17, 2021
RICHLAND, Wash.—Researchers have compiled the most comprehensive road map of the protein composition of human lungs, providing a clearer picture of the healthy development of this essential organ that made terrestrial life possible. Credit: Illustration by Stephanie King and Geremy Clair | Pacific Northwest National Laboratory RICHLAND, Wash.—Researchers have compiled the most comprehensive road map […].
NY Times
NOVEMBER 17, 2021
The Biden administration will spend billions of dollars on a new plan to combat the pandemic, investing in antiviral pills, rapid tests and manufacturing.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Scienmag
NOVEMBER 17, 2021
Northwestern University researchers have invented a new high-resolution camera that can see the unseen — including around corners and through scattering media, such as skin, fog or potentially even the human skull. Credit: Florian Willomitzer/Northwestern University Northwestern University researchers have invented a new high-resolution camera that can see the unseen — including around corners and […].
BioSpace
NOVEMBER 17, 2021
Avilar Therapeutics officially joined the game with $60 million in seed financing from RA Capital Management.
Scienmag
NOVEMBER 17, 2021
Filling in the links of the evolutionary chain with a fossil record of a ‘‘snake with four legs” connecting lizards and early snakes would be a dream come true for paleontologists. But a specimen formerly thought to fit the bill is not the missing piece of the puzzle, according to a new Journal of Systematic […].
BioSpace
NOVEMBER 17, 2021
Her career as a physician and scientist is guided by a combination of logic and creativity.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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